Job Information
Amgen Regulatory Affairs Senior Associate in Tokyo, Japan
Group Purpose
Facilitate patient access to Amgen products in Japan through executing the development and regulatory plan s ; providing strategic regulatory expertise; interfacing with agencies on regulat ors ; aligning with key cross-functional partners; integrating into Amgen’s commercialization process, and continuously improving our processes and developing our talent
Job Summary
This role supports regulatory and commercialization activities for Amgen products in Japan leading by RA Manager or Senior Manager. This role also supports development and maintenance of good relationship with Japanese Health Authorities to facilitate drug approvals. This role may provide regulatory guidance and support various Amgen teams by involving Japan Project Team and Global Product Team.
Live
What you will do
Responsibilities:
Support RA Manager or Senior Manager to coordinate and conduct PMDA consultations from planning to finalization of the official minutes
Support kick-off meetings for local regulatory deliverables including Clinical Trial Notification (CTN), New Drug Application (NDA) submissions, and agency interactions by RA Manager or Senior Manager
Work cross-functionally with the various Amgen teams to support activities related to CTNs and NDAs
Assemble and provide local regulatory input to a variety of local and global teams in a timely manner
Execute and maintain compliance for all documents to be submitted to Health Authorities
Win
What we expect of you
Qualifications
Bachelor’s degree and 6 years of directly related experience including 3+ years of experience in Regulatory Affairs
Over 10 years experiences in Research & Development of pharmaceutical industry including at least 5 years experiences in regulatory affairs with experiences for supporting PMDA consultations and CTN submission of pharmaceuticals in Japan
Team work] working in matrix environments including global teams as the One Team
Communication skills in both Japanese and English
Ability to understand scientific/clinical information
Support a few projects in parallel
Computers: Microsoft Outlook/ Word/ Excel/Power Point